Type 2 Diabetes Clinical Trial
Official title:
A Comparison of the Pharmacodynamic and Pharmacokinetic Properties of Oral Insulin vs. s.c. Regular Insulin in Type 2 Diabetic Patients
This study compared the pharmacokinetic and pharmacodynamic properties of an oral insulin formulation with that of a standard subcutaneous injection of regular human insulin.
This study was a single centre, randomized, 3-period crossover study performed in patients
with type 2 diabetes. Patients received single doses of an oral insulin formulation and
subcutaneous regular human insulin on separate visits.
The primary objective of this study was to compare the pharmacokinetic and pharmacodynamic
properties of an oral insulin formulation with that of 15 U subcutaneous injected regular
human insulin.
Pharmacokinetic and pharmacodynamic parameters including bioavailability and bioefficacy
were measured during 6-hour glucose clamp experiments.
Study duration: 2 months
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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